Adverse drug reaction reporting quality among different health professionals and the contribution of clinical pharmacists: A pilot study

What is known and objective Adverse drug reaction (ADR) reporting is generally of poor quality, which may delay post‐marketing regulatory actions. Here, we evaluated the quality of ADR reporting at our institution and examined the roles of clinical pharmacists in this process. Methods We retrospectively reviewed ADR reports at our hospital between 2017 and 2019 to assess the number, source, drugs, and routes of administration. The quality assessment of ADR case reports form issued by the China Adverse Drug Reaction Monitoring Centre was used to assess the quality of ADR reports. Quality scores of ADR reports from pharmacists and nonpharmacists were assessed before and after review by clinical pharmacists. Results and discussion Reports of adverse drug reaction reporting by healthcare professionals increased annually, with 59, 77 and 82 reports submitted in 2017, 2018 and 2019, respectively. The numbers of new or serious ADR reports by healthcare professionals in 2017, 2018, and 2019 were 5 (8.47%), 77 (11.69%) and 82 (10.98%), respectively. New or serious ADR reports accounted for approximately 10% (23/218) of all reported cases, and more than 70% (158/218) of the reports were from pharmacists. Systemic administration accounted for more than 80% (233/265) of adverse reactions, whereas ADRs due to topical drug use were rarely reported. The drugs that reportedly triggered ADRs were mainly antibacterial and patented Chinese medicines and accounted for more than half of all reported cases. The scores of ADR reports from pharmacists and nonpharmacists before modification by clinical pharmacists were 86.69 ± 8.12 and 68.36 ± 5.94, respectively, and the scores of ADR reports from pharmacists and nonpharmacists after modification by clinical pharmacists were 91.14 ± 6.64 and 90.02 ± 5.63, respectively. What is new and conclusion In a real‐world setting, pharmacists are commonly responsible for most ADR reports. The quality of ADR reports from pharmacists and nonpharmacists before review did not reach the standard of excellence. An audit of clinical pharmacists may improve the overall quality of ADR reports. However, under‐reporting of adverse reactions still occurs. Reports of adverse drug reactions (ADRs) are the basis of post‐marketing drug surveillance. In this study, we aimed to assess the contributions of clinical pharmacists to the quality of ADR reports. All ADR reports analysed in this study were collected from Fudan University Eye, Ear, Nose and Throat Ho